1. Field of the Invention
This invention relates to therapeutic intervention methods, such as gastric occlusion methods, employing implantable balloon structures formed of laminate films, and to related therapeutic devices.
2. Description of the Related Art
In the field of polymeric film technology, involving polymeric sheet stock or web-form material, typically having a thickness of less than about 25 mils, there is a need for gas-barrier films.
Such gas barrier films may be employed for containment of a specific gas when used to form gas receptacles, or as a packaging, cushioning or preservative structure (e.g., when fabricated to contain gas species such as oxygen, nitrogen, argon, helium, carbon dioxide, water vapor, etc). Still other applications relate to the prevention or reduction of gas passage through the film, such as in instances in which any significant penetration of gas through the film may adversely impact an article, structure, material or region that is isolated from an adverse gas environment by the gas barrier film.
In the aforementioned applications, the film material may be susceptible to forces and consequent stresses that cause failure of the film, e.g., by cracking, tearing, splitting, stress-softening, embrittlement or other material failure mechanisms.
Specific applications of such gas barrier films may include the requirement of biocompatibility, in which the gas barrier film is required to function in or in connection with a physiological environment, whereby the film may be subjected to exposure to biological fluids, variations of temperature, pressure and pH, etc.
There is presently a compelling need in the art for readily manufacturable, soft and supple yet durable and reliable gas barrier films for manufacture of medical devices as well as a wide variety of other product articles.